Protocol / Study Number: / Sponsor Name:
Principal Investigator Name: / Site Number:
Site Name (if applicable)
*THIS FORM IS TO BE COMPLETED BY ALL PERSONNEL INVOLVED IN THE STUDY AFTER RECEIVING PROPER STUDY TRAINING AND PRIOR TO TAKING PART IN ANY STUDY ACTIVITIES
Principal Investigator (PI)
By signing, I confirm/acknowledge that the tasks listed below will only be delegated to appropriately trained, skilled and qualified staff. I will remain responsible for the overall study conduct and reported data and I will ensure study oversight. All associates, colleagues, and employees assisting in the conduct of the study are informed about their obligations, and have not performed any study tasks prior to appropriate delegation and completion of appropriate training. Mechanisms are in place to ensure that site staff receives the appropriate information and training throughout the study and that a 2-way communication channel exists between staff and self. Any changes in staff or delegation in staff will be recorded in a timely manner.
Name / Principal Investigator’s Signature / Initials / Start(dd/mmm/yyyy) / End
(dd/mmm/yyyy)
(complete only if prior to end of study)
Site Staff
Name / Signature / Initials / Study Role / Key Study Task(s)(choose from list below) / Start
(dd/mmm/yyyy) / End
(dd/mmm/yyyy) (complete only if prior to end of study) / PI Initials & Date
(dd/mmm/yyyy) /
__/___/_____
__/___/_____
__/___/_____
__/___/_____
__/___/_____
__/___/_____
__/___/_____
__/___/_____
__/___/_____
__/___/_____
__/___/_____
__/___/_____
Comments:
Electronic Signature Declaration for Principal Investigator and Site Staff
· My electronic signature as it applies to entering electronic data or signing records in sponsor-owned or sponsor -outsourced computer systems is the legally binding equivalent of my handwritten signature.
· I will not share password(s) assigned to me for this study with any other persons.
Principal Investigator’s End of Study Declaration
I hereby confirm that the above information is accurate and complete, and that I authorized the delegation of study-related tasks to each individual as listed above.
Principal Investigator’s Signature: Date:
Task Key:
2. Subject selection/recruitment* / 13. Sample processing and/or shipment
3. Confirm eligibility (review inclusion/exclusion criteria)* / 14. Evaluate study-related test results *
4. Obtain medical history (source documents) / 15. Use IWRS/IVRS
5. Perform physical exam* / 16. Make entries/corrections on (e)CRFs
6. Conduct study visit procedure as outlined in the protocol* / 17. Sign- off (e)CRFs*
7. Make study-related medical decisions* / 18. Maintain essential documents
8. Assess AEs/SAEs* / 19. Perform study-related assessments as per protocol *
9. Dispense study drug* / 20. Complete company- specific log ( if applicable)
10. Perform drug accountability / 21. Other (specify)______
11. Study drug storage and temperature monitoring / 22. Other (specify) ______
*These tasks may only be performed by qualified individual as permitted by local law, medical or standard of care practices, or applicable required training as per job description or designation.
www.transceleratebiopharmainc.com Delegation of Responsibility Form v 3.0 August 13, 2014
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